- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06342531
More Effective Violence Risk Management - eDASA+APP FI (eDASA+APP FI)
March 26, 2024 updated by: Tella Lantta, University of Turku
More Effective Violence Risk Management for Psychiatric Wards - eDASA+APP FI
The main goal of this study is to evaluate if the Finnish version of eDASA+APP (electronic Dynamic Appraisal of Situational Aggression + Aggression Prevention Protocol), a clinical decision support system (CDSS), has an impact on reducing workplace violence, use of coercive measures and increasing nurses' job satisfaction in adult psychiatric inpatient care.
Study Overview
Detailed Description
The study includes three phases: 1) exploring attitudes of nurses and nurse managers towards validated tools, violence risk assessment and management, 2) a pre-implementation including a co-design process of the eDASA+APP to ensure optimal integration and adaptation to local context and integration into the local EPIC based EHR system together with relevant stakeholders (health care staff and expert-by-experience), and 3) a quasi-experimental implementation study to evaluate the impact of the intervention (eDASA+APP FI).
Study Type
Interventional
Enrollment (Estimated)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tella Lantta, PhD
- Phone Number: +358504756068
- Email: tella.lantta@utu.fi
Study Contact Backup
- Name: Maria Ameel, PhD
- Phone Number: +358504600510
- Email: maria.ameel@hus.fi
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- adult psychiatric wards
Exclusion Criteria:
- psychiatric wards specialized only for the care of people with intellectual disabilities, wards providing care for both adults and underaged patients (eating disorder units)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: eDASA+APP FI
Nurses in the study wards are using a CDSS 'eDASA+APP FI' in their daily clinical work to aid their short-term violence risk assessment and management, together with a patient if possible, to identify patients at elevated risk for violence in the coming 24 hours and to decrease (or maintain low) the risk with evidence-based, non-invasive nursing interventions.
|
A CDSS for nurses to assist in their daily short-term violence risk assessment and management, is integrated into an EPIC-based EHR system.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Workplace violence
Time Frame: Pre-post (3 months)
|
Violence experienced by healthcare staff in the wards, routinely collected data
|
Pre-post (3 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Coercive measures
Time Frame: Pre-post (3 months)
|
Routinely monitored and collected by the wards according to the Finnish Mental Health Act
|
Pre-post (3 months)
|
Job satisfaction
Time Frame: Pre-post (3 months)
|
Nurses yearly job satisfaction survey will be used (Nurse Engagement Survey (NESplus))
|
Pre-post (3 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Tella Lantta, PhD, Department of Nursing Science, University of Turku, Finland
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2024
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
March 26, 2024
First Submitted That Met QC Criteria
March 26, 2024
First Posted (Actual)
April 2, 2024
Study Record Updates
Last Update Posted (Actual)
April 2, 2024
Last Update Submitted That Met QC Criteria
March 26, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 210324
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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